Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-06-30

Brief Summary

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Observing how cocoa effects the cardiovascular and renal system.

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Detailed Description

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Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cocoa

Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure \<165/105

Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No